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RPM-FED: Relapse Predicting Model for First Episode Depression

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02942251
Collaborator
(none)
300
Enrollment
6
Arms
36
Duration (Months)

Study Details

Study Description

Brief Summary

Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical features and medication
  • Other: Psycho-social
  • Other: immunology
  • Other: Laboratory abnormality
  • Other: Comorbidity
  • Other: Treatment as usual
 N/A

Detailed Description

Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

This study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.

Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clinical features and medication

A group patients with significant high risk of clinical features and medications.

Other: Clinical features and medication
This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
Experimental: Psycho-social

A group patients with significant high risk of psycho-social problems.

Other: Psycho-social
This group will be suggested to add on psychotherapy on medical treatment.
Experimental: immunology

A group patients with significant high risk of immune disturbance.

Other: immunology
This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
Experimental: Laboratory abnormality

A group patients with significant high risk of Laboratory abnormalities.

Other: Laboratory abnormality
This group will be suggested to more safety antidepressants.
Experimental: Comorbidity

A group patients with physical or mental disorders comorbidities.

Other: Comorbidity
This group will be suggested to treat their comorbidities as well as treat MDD.
Experimental: Treatment as usual

Control group.

Other: Treatment as usual
Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
Other Names:
  • Treatment as usual(TAU)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HAM-D total score [12 weeks]

      The change from baseline to end of study (EOS) in HAM-D total score

    Secondary Outcome Measures

    1. Time to relapse [12 months]

      The time to new intervention for an emerging mood episode

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age from 18 to 65 years old;

    • Han Chinese;

    • Outpatient and inpatient patients;

    • Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)

    • Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;

    • Written informed consent was given;

    • Junior high school education and above, with enough audio-visual ability to accomplish the visits;

    • Normally resident in one country and had a residential address, able to follow-up.

    Exclusion Criteria:

    • Bipolar disorder rapid cycling or mixed episode;

    • Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;

    • Severe personality disorder, metal retardation, anorexia/bulimia nervosa;

    • Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);

    • Female patients who were pregnant, planning to be pregnant or breast feeding;

    • Severe medical or neurological problems.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    • Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT02942251
    Other Study ID Numbers:
    • Pending
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Oct 26, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Shanghai Mental Health Center
    MDD
    big data analytics
    Additional relevant MeSH terms:
    Depressive Disorder
    Depressive Disorder, Major

    Study Results

    No Results Posted as of Oct 26, 2016